Periodic Reporting for period 1 - CareInTrials (Care in Clinical Trials involving Youth. Exploring Vulnerability through Empirical Philosophy in a Clinical Trials Unit.)
Reporting period: 2021-04-01 to 2023-03-31
In the 20th century, ethics debates and guidelines on children’s participation in clinical trials and biomedical research have shifted from the need to protect them from research to the need to protect them through research. The initial precautionary approach that gave pivotal attention to individual autonomy and appealed for protection of vulnerable subjects, has been gradually turned into an approach centered on the need for foundational data to achieve evidence-based pediatric medicine. These debates focus on “what’s right to do” for minors, but do not generally consider their perspectives nor discuss critical understandings of childhood. Given the increasing literature in bioethics that values the combination of empirical and philosophical methods, CareInTrials suggests a shift in focus for research ethics discussions in pediatrics: it centers on decision making in clinical trials and in participants’ narratives and perspectives.
CareInTrials is an empirical philosophy study, which makes use of qualitative methods to provide a philosophical reading of the experiences of youth participating in clinical trials. It pursues three main objectives: 1) it analyzes how international ethical guidelines and regulations have problematized the ethical issues at stake with minors’ participation in research over the years; 2) it observes the daily interactions and communications related to adolescents’ (aged 12-17 y.o.) participation in clinical trials, 3) it explores the meaning making of adolescents (12-17 y.o.) participating in clinical trials, their parents and healthcare professionals.
To meet these objectives, three main methods were used: 1) a document analysis of research ethics guidelines and regulations involving human subjects from 1947 until today; 2) a 9 months ethnographic observation study at La Paz University Hospital; 3) 23 semi-structured interviews with different actors involved in clinical trials (namely, adolescents aged 12-17 years old currently enrolled in clinical trials, their accompanying adults and healthcare workers).
The material thus collected was analyzed through a philosophical analysis that engages with critical understandings of childhood in human and social sciences, the lived experience, and the existential dimension in medicine. A secondment at the “Science, Philosophy and History” (SPHERE) Research Unit (CNRS - University of Paris) was part of the action.
CareInTrials provided insights to current ethical debates and recommendations on pediatric clinical trials and more broadly for pediatric health research and innovation. The philosophical analysis of the experiences and narratives of different actors involved allowed to: 1) highlight the changing perspectives on childhood in biomedical research, 2) provide in-depth accounts of real life situations that show the complexity and nuances that theoretical changes bring to practice, 3) highlight some ethical aspects that could be improved.
CareInTrials is an empirical philosophy study, which makes use of qualitative methods to provide a philosophical reading of the experiences of youth participating in clinical trials. It pursues three main objectives: 1) it analyzes how international ethical guidelines and regulations have problematized the ethical issues at stake with minors’ participation in research over the years; 2) it observes the daily interactions and communications related to adolescents’ (aged 12-17 y.o.) participation in clinical trials, 3) it explores the meaning making of adolescents (12-17 y.o.) participating in clinical trials, their parents and healthcare professionals.
To meet these objectives, three main methods were used: 1) a document analysis of research ethics guidelines and regulations involving human subjects from 1947 until today; 2) a 9 months ethnographic observation study at La Paz University Hospital; 3) 23 semi-structured interviews with different actors involved in clinical trials (namely, adolescents aged 12-17 years old currently enrolled in clinical trials, their accompanying adults and healthcare workers).
The material thus collected was analyzed through a philosophical analysis that engages with critical understandings of childhood in human and social sciences, the lived experience, and the existential dimension in medicine. A secondment at the “Science, Philosophy and History” (SPHERE) Research Unit (CNRS - University of Paris) was part of the action.
CareInTrials provided insights to current ethical debates and recommendations on pediatric clinical trials and more broadly for pediatric health research and innovation. The philosophical analysis of the experiences and narratives of different actors involved allowed to: 1) highlight the changing perspectives on childhood in biomedical research, 2) provide in-depth accounts of real life situations that show the complexity and nuances that theoretical changes bring to practice, 3) highlight some ethical aspects that could be improved.
The first part of this work consisted in a critical document analysis concerning guidelines and regulations in pediatric biomedical research from 1947 until nowadays. Dr Murano is in the final phase of writing a first article on this topic. This paper highlights that there has been a shift from considering children as vulnerable subjects of research, to being protected, to being active participants with their own rights. Such transformation proposes conceptions of children’s autonomy and vulnerability that are profoundly different. Yet, research ethics debates do not generally interrogate philosophical and societal conceptions of childhood, which could help make sense of current sometimes contradictory guidelines and regulations.
The largest part of CareInTrials, however, consisted in conducting fieldwork at the units of Hospital La Paz conducting clinical trials with adolescentes. Before starting this part of the project, we received approval from the Research Ethics Committee of La Paz University Hospital (CEIm, with approval number: PI-4809). Dr Murano then conducted 9 months of ethnographic observations and 23 interviews (of which 9 with minors aged from 12 to 16 years old, 6 accompanying adults and 8 healthcare professionals) in four different trial settings and disciplines: 1) the development of an anti-COVID-19 vaccine, 2) studies on two dermatological diseases, e.g. atopic dermatitis and psoriasis, 2) studies on hemophilia and 3) on the PIK3CA-related overgrowth spectrum. The fieldwork ended in July 2022 and now we are working on the analysis. Some preliminary results highlight the differences of understanding of childhood by different stakeholders (youth, parents, professionals), the focus on trust in others and in science as primary reasons to participate in clinical trials, the absence of reflections on emotions in these settings and the constraints related to current organization of clinical trials practices.
The largest part of CareInTrials, however, consisted in conducting fieldwork at the units of Hospital La Paz conducting clinical trials with adolescentes. Before starting this part of the project, we received approval from the Research Ethics Committee of La Paz University Hospital (CEIm, with approval number: PI-4809). Dr Murano then conducted 9 months of ethnographic observations and 23 interviews (of which 9 with minors aged from 12 to 16 years old, 6 accompanying adults and 8 healthcare professionals) in four different trial settings and disciplines: 1) the development of an anti-COVID-19 vaccine, 2) studies on two dermatological diseases, e.g. atopic dermatitis and psoriasis, 2) studies on hemophilia and 3) on the PIK3CA-related overgrowth spectrum. The fieldwork ended in July 2022 and now we are working on the analysis. Some preliminary results highlight the differences of understanding of childhood by different stakeholders (youth, parents, professionals), the focus on trust in others and in science as primary reasons to participate in clinical trials, the absence of reflections on emotions in these settings and the constraints related to current organization of clinical trials practices.
This is an empirical philosophy study, which makes use of qualitative methods to provide a philosophical reading of adolescents’ participation in clinical trials. It allowed us to enrich current studies in research ethics by providing real life narratives and descriptions of situations in a public hospital in Spain. It confronts biomedical with humanities and social sciences understandings of childhood. This combination is particularly interesting because it allows us to consider children not merely as patients but as social actors with their own rights, and study the complexities that these accounts bring to a world that has previously always considered them as passive and vulnerable subjects. It also confronts theoretical positions on what is ethical to do in circumstances related with clinical trials with in-depth descriptions of what people think and do when they actually are involved in such practices. It focuses on the human and relational aspects over the biomedical and bureaucratic ones.
These results might be of interest for all minors volunteering in clinical trials and their families, as well as healthcare professionals in charge of the care of these people. It has also broader relevance for advancing current regulations and ethical guidelines on pediatric health research and could help pharmaceutical companies in setting priorities in the design and development of research projects.
These results might be of interest for all minors volunteering in clinical trials and their families, as well as healthcare professionals in charge of the care of these people. It has also broader relevance for advancing current regulations and ethical guidelines on pediatric health research and could help pharmaceutical companies in setting priorities in the design and development of research projects.